There are a number of potential problems that can arise when delivering two active medicaments or “agents” simultaneously. The two active agents may interact with each other during the long-term, shelf life storage of the formulation. Therefore, there are certain advantages to storing the active components separately and then combining them at the point of delivery, e.g. injection, need-less injection, pumps, or inhalation. However, the process for combining the two agents needs to be straightforward and convenient for the user to perform reliably, repeatedly and safely.
A further potential concern is that the quantities and/or proportions of each active agent making up the combination therapy may need to be varied for each user or at different stages of their therapy. For example, one or more active agents may require a titration period to gradually introduce a patient to a “maintenance” dose. A further example would be if one active agent requires a non-adjustable fixed dose while the other is varied in response to a patient's symptoms or physical condition. This potential problem means that pre-mixed formulations of multiple active agents may not be suitable as these pre-mixed formulations would have a fixed ratio of the active components, which could not be varied by the healthcare professional or user.
Additional concerns may arise where a multi-drug compound therapy is required, because certain users cannot cope with having to use more than one drug delivery system or making the necessary accurate calculation of the required dose combination. This is especially true for users with dexterity or computational difficulties.
Other potential problems can arise where a user attempts to re-use a non-sterile needle assembly after a certain dose combination has been delivered. Using such non-sterile needle assemblies could lead to the transmission of certain diseases (septicemia) and, therefore, there exists a need for a medicated module that prevents needle re-use. There is a further concern of inadvertent needle sticks with certain needle assemblies where the injection needle is not concealed or covered, especially after use when a needle may be contaminated with blood. As such, there is also a general need to reduce certain patient's needle anxiety that may heighten a patient's fear or phobia of exposed needles. The medicated modules of the present disclosure may help to reduce this anxiety.
As described herein, in one situation, a patient would attach a medicated module to the drug delivery device in order to deliver the required combination dose of medication comprising a selected dose of the first medicament and a fixed dose of the second medicament. Following the administration of this combined dose, the single dose of medication within the medicated module would have been used and so features on the medicated module (such as a locking needle guard and/or visual warnings) would help to prevent the patient from being able to inject a second (non-combination) dose through the medicated module. A patient or user of the device would therefore be required to remove the used or spent medicated module and to attach a new medicated module to the drug delivery device for each dose administration.
An increasing number of drug delivery devices, such as pen-type drug delivery devices, are being marketed, including ones that are used for the delivery of different types of drugs. The issue of evident device and/or drug differentiation is becoming of increased importance as certain safety issues (some life-threatening) may arise which are associated with a patient or user mistaking one drug delivery device for another device and then administering an incorrect or wrong drug. While device/drug differentiation can be achieved in a number of ways, a preferable method of differentiation is mechanical prevention (i.e. making it difficult or nearly impossible for a device/drug mix up to occur). As just one example, a number of commercially available pen-type drug delivery devices are supplied with a coupling mechanism that is non-proprietary. That is, the coupling mechanism accommodates the attachment of a conventional Type A needle assembly according to EN ISO 11608-2:200 via a helical thread. Such a type A needle assembly may comprise an outer diameter of about 9.5 mm and an inner diameter of about 8.9 mm. The pitch may arise to 0.8. For the ‘mono-product’ devices, the use of different Type A needle assemblies is acceptable, as the needle assembly in this instance is simply the means of administering the medicament from the primary reservoir of the drug delivery device.
This may not be the case for the presently disclosed medicated module and systems, where inadvertent use of a medicated module with a non-approved primary drug delivery device could have serious consequences. Such consequences could include unknown health risks as the two formulations may not have been subject to any clinical evaluation or perhaps lacks regulatory approval. Equally, the use of a standard Type A needle with the approved primary drug delivery device may not be desirable, as a patient would not receive the targeted combination dose. In one situation, this might result in reduced therapeutic efficacy. However, in a worse situation, use of a standard Type A needle with the approved primary drug delivery device could result in non-desirable side effects, e.g. in the instance where the secondary medicament had some kind of balancing, cancelling or delaying effect on the pharmaco-kinetics (“PK”) and/or pharmaco-dynamics (“PD”) of the primary medicament contained within the drug delivery device. There are, therefore, certain safety and clinical benefits to configuring a combination delivery device which may prevent attachment of the medicated module to an incorrect primary drug delivery device. There are also, therefore, certain benefit, e.g. regarding safety and clinical benefits, to configure a combination delivery device so as to prevent attachment of a standard or conventional Type A needle to the combination therapy's primary drug delivery device.
Accordingly, there exists a need to provide devices and methods for the delivery of two or more medicaments in a single injection or delivery step that is simple and safe for the user to perform and that also tends to reduce a patient's anxiety towards injections or needles or combinations of drug therapies. The presently disclosed dedicated needle assemblies and administration systems overcome the above-mentioned concerns by providing separate storage containers for two or more active drug agents that are then combined and/or administered during a single delivery procedure. Such devices may be provided in separate storage containers or provided in a kit form comprising at least one medicated module and at least one non-medicated module with dedicated attachments between each other.
Setting a dose of one medicament may automatically fix or determine the dose of the second medicament (i.e. a non-user settable medicament). The present disclosure may also give the opportunity for varying the quantity of one or both medicaments. For example, one fluid quantity can be varied by changing the properties of the injection device, e.g. by dialling a user variable dose or changing the device's “fixed” dose. The second fluid quantity can be changed by manufacturing a variety of secondary drug containing packages or kits with each variant containing a different volume and/or concentration of the second active agent. The user or healthcare professional would then select or prescribe the most appropriate secondary package or series or combination of series of different packages or kits for a particular treatment regime. These and other advantages will become evident from the following more detailed description of the invention.